Phase 2 Study of 18F-mFBG PET Imaging to Measure Heart Nerve Function in People With and Without Lewy Body Diseases

What this Trial Is About

Researchers are evaluating the use of the radiopharmaceutical 18F-mFBG as an imaging agent to measure how neurodegenerative diseases affect the hearts sympathetic nervous system, particularly in people with Lewy body diseases like Parkinsons disease and Lewy body dementia. This Phase 2 study aims to compare 18F-mFBG imaging results between subjects with Lewy body disease and those with non-Lewy body neurological diseases, using historical data from healthy individuals for reference. The study addresses challenges in current imaging techniques and explores improved methods for quantifying myocardial sympathetic innervation. Participants will receive an intravenous injection of 222-370 MBq 6-10 mCi of 18F-mFBG. Imaging will be performed twice a whole-body scan from the head to the pelvis will be done 30 minutes after injection, and a static image of the chest area will be taken at 60 minutes. The study includes two groups one with known or presumed Lewy body disease and another with neurological diseases not related to Lewy bodies. Both groups undergo the same imaging procedure. Throughout the study, participants will undergo PETCT or PETMR scans to assess the extent and regional reduction of 18F-mFBG uptake in the heart and whole body. Researchers will analyze quantitative imaging data to distinguish differences between the groups. The study duration for outcome measurements is up to six months, during which participants remain clinically stable. Safety and imaging effectiveness will be carefully monitored, with the total study completion expected by December 2026.

18F-mFBG Cardiac Uptake With Lewy Body Dementia